Chapter 20 - Conflict of Interest
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Requirements for University Members
See Chapter 8 for information about conflict of interest (COI) review for human subject research. Additional information regarding COI requirements is available on the Conflict of Interest Division (COID) website.
Review and Management of University Member COIs
Human subject research may involve individual or institutional COIs. The COID, and, in some instances, the Conflict of Interest Committee or Institutional Conflict of Interest Committee, will determine when a Conflict Management Plan (CMP) is necessary. The executed CMP will be attached to the COID’s ancillary review in PittPRO.
For information about CMPs managing individual COIs, refer to the Individual Conflicts of Interest page. For information about CMPs managing institutional COIs, refer to the Institutional Conflicts of Interest page.
The decision to grant approval of the protocol remains with the IRB. For the purpose of protecting the rights and welfare of human subjects, this includes an assessment of the CMP requirements underwhich the research would be conducted for individual and institutional COIs.
IRB Members
IRB members, alternate members, and consultants who are affiliated with the University of Pittsburgh and who are identified as mandatory disclosers must complete an Annual Disclosure Certification in MyDisclosures.
IRB members who are considered unaffiliated with the institution will not be required to complete the standard conflict of interest form. These members will be required to sign a statement at the time of their orientation indicating that the conflict of interest policy has been provided to them.
To ensure understanding of Conflict of Interest (COI) issues, all members will be provided with the University definitions of COI at the time of their orientation. In addition, the COI Policy will be reviewed on an annual basis with all committee members.
Evaluations of Potential Conflicts at Meetings
No IRB member, alternate member, or consultant may be involved in the review of a research study in which they have a COI as defined herein, except to provide information as requested. It is the responsibility of the IRB member, alternate member, or consultant to disclose any COI related to a research study and to recuse themselves on that research study. Prior to final approval of the study, Designated Reviewers for exempt and expedited studies will attest that they do not have a conflict.
An IRB member, alternate member, or consultant has a COI that requires recusal when they or a member of their immediate family:
- Are involved in the design, conduct, or reporting of the research study;
- Has a significant financial interest, as defined under University Policy RI 01, related to the research study; or
- Has another interest that conflicts with their ability to objectively review the research study.
IRB members, alternates, and consultants are polled upon initiation of each IRB meeting to determine if they (or a member of their immediate family) are a listed investigator on any research study being reviewed at the meeting or has a COI as defined above. When an IRB member, alternate member, or consultant has a COI in a research study that requires recusal, they will leave the virtual meeting during the relevant discussion and vote.
Documentation in Minutes
The absence of IRB members, alternates, or consultants due to a conflict (i.e., a listed investigator, financial or other conflict) during the discussion of the research protocol and the vote will be documented in the minutes of the full board IRB meeting to include the reason for their absence.
Investigators
- Research investigators are not permitted to participate in decisions relating to the selection of IRB members responsible for performing the review of their research studies.
- Investigators must disclose if they have any of the significant financial interests listed in the COI section of the protocol application that are related to the research covered by the IRB protocol.
- As outlined in Chapter 8, for research studies submitted for initial and continuing IRB review, the Conflict of Interest Office is notified if the investigator indicates that there is a conflict of interest.
- Investigators who have a financial conflict of interest (FCOI) with research covered under an IRB protocol must agree to a Conflict of Interest Management Plan (CMP) developed by the COI Office or Committee, consistent with the requirements outlined in University Policy RI01. Investigator disagreement with the CMP should be directed to the COID.
In the unlikely event that the IRB is not in agreement with the proposed COI management plan and an agreement cannot be reached following the above procedures, the decision to grant IRB approval of the protocol remains with the IRB. This includes an assessment (for the purpose of protecting the rights and welfare of the human subjects) of the COI provisions under which the research would be conducted.
Requirements for Vice Chairs
Research submissions will not be placed on the agenda of an IRB committee meeting if the IRB Vice Chair who will preside over the meeting is a listed investigator on the submission or holds a significant financial interest in the sponsor of the research or the technology being evaluated. Under extenuating circumstances, exceptions to this policy can be made by the IRB Chair or designee. In the event an exception is deemed necessary, the conflicted IRB Vice Chair will leave the virtual meeting during the relevant discussion and vote during the review, discussion and vote of the research submission. Another IRB Committee member will act as vice chair for that portion of the meeting and will review and approve the minutes related to the study where the conflict exists.
4/11/25